Post-Approval Studies

Post-Approval Studies

In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).

The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.

CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.

In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

The CABANA study is a multi-center surveillance registry. The objectives of the registry are to:

1) to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice, 2) to evaluate clinical outcomes using the death, stroke, and myocardial infarction rate at 30 days or less, in total and by center experience tier, and 3) to assess the adequacy of the Boston Scientific Corporation Carotid Stenting Training Program.
The CABANA study is a multi-center surveillance registry. The objectives of the registry are to:

1)

to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice, 2) to evaluate clinical outcomes using the death, stroke, and myocardial infarction rate at 30 days or less, in total and by center experience tier, and 3) to assess the adequacy of the Boston Scientific Corporation Carotid Stenting Training Program.

Study Population Description

The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or co-morbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease. This includes patients with neurological symptoms and > 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram and patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system,

is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or co-morbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease. This includes patients with neurological symptoms and > 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram and patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

Sample Size

1,500 patients, 150 sites

Data Collection

The endpoint for the 1,000 newly enrolled patients will be a 30-day composite death, stroke and myocardial infarction
The endpoint for the 1,000 newly enrolled patients will be a 30-day composite death, stroke

and myocardial infarction

Followup Visits and Length of Followup

Patients will be followed at 30 days and annually through 3 years.

Final Study Results

Actual Number of Patients Enrolled

1097

Actual Number of Sites Enrolled

99

Patient Followup Rate

95%

Final Safety Findings

Of the 1,025 subjects evaluable for 30-day postprocedure MAE, 0.5% (5/1,025) had MIs, 3.3% (34/1,025) had strokes, and 1.3% (13/1,025) had CEC-adjudicated deaths, contributing to an overall CEC-adjudicated MAE rate of 4.6% (47/1,025). Out of the 34 subjects who had strokes within 30 days postprocedure, the majority (58.8%; 20/34) had strokes that were classified as ¿major,¿ while the rest (41.2%; 14/34 ) had strokes classified as ¿minor.¿ In almost all of the 34 subjects with stroke, the stroke was on the ipsilateral side (88.2%; 30/34) and in most cases the stroke was considered ischemic (85.3%; 29/34).
Of the 1,025 subjects evaluable for 30-day postprocedure MAE, 0.5% (5/1,025) had MIs, 3.3% (34/1,025)

had strokes, and 1.3% (13/1,025) had CEC-adjudicated deaths, contributing to an overall CEC-adjudicated MAE rate of 4.6% (47/1,025). Out of the 34 subjects who had strokes within 30 days postprocedure, the majority (58.8%; 20/34) had strokes that were classified as ¿major,¿ while the rest (41.2%; 14/34 ) had strokes classified as ¿minor.¿ In almost all of the 34 subjects with stroke, the stroke was on the ipsilateral side (88.2%; 30/34) and in most cases the stroke was considered ischemic (85.3%; 29/34).

Final Effectiveness Findings

The sponsor reports that system technical success was achieved in 97.1% of evaluable subjects.

Study Strengths and Weaknesses

The sponsor reports good follow-up of study subjects. However, the study may not have been adequately powered to detect rare adverse events.
The sponsor reports good follow-up of study subjects. However, the study may not have been